The EAMS as announced today looks quite different to the kind of structure we discussed during the consultation period and contains many of the elements I commented upon in an earlier blog post in January. I provide some detail below but in short it has some positive and progressive elements (the new Promising Innovative Medicines (PIM) designation, mirroring the US Breakthrough therapy Designation the BIA specifically highlighted to government), some disappointing news (a lack of any dedicated funding or reimbursement to support ongoing research, development and innovation) and aspects which will require further detail (a new NICE assessment framework for these early access medicines and rapid commissioning).

The positive
The BIA certainly welcomes the plans to introduce a PIM designation and early access scheme. This has the potential to reduce the time it takes to get innovative, clinically effective treatment to the patients who need them in areas of serious unmet medical need. However, I do worry that by deciding not to fund the scheme the government is undermining its attractiveness to UK SMEs and to global corporations choosing the UK as a location for their clinical trials and runs the risk of the scheme being under-utilised.

Explainer event 28 April
I very much hope that won’t be the case as the scheme offers an important change to the regulatory framework in the UK and the speed with which patients can access new medicines. The BIA remains committed to working in partnership with all stakeholders to ensure the scheme is globally competitive. With this in mind, the BIA, in partnership with the ABPI, will host a “one stop shop” half day explainer event on 28 April in London designed for the whole sector- industry, medical research charities, academia and patient groups – to come together, hear the detail from the policymakers, and discuss how to make a success of this. Save this date – I’d encourage stakeholders to attend.

George Freeman MP, who has been instrumental in the final iteration of the EAMS and ensuring it was announced, will speak at that event and I can pay tribute to his work behind the scenes to get the announcement we have today. George’s role as a UK trade envoy and detailed knowledge of this scheme, will be important in explaining it around the world and in some media coverage today you will see there is optimism for companies including Summit and their lead product in Muscular Dystrophy, a perfect example of the kind of innovative product for an area of unmet need that should benefit from this.

No dedicated funding
We know that the scheme will not have a dedicated funding pot and there is not an opportunity for early reimbursement envisaged at present. Government know well that the BIA have consistently called for a centrally funded reimbursement procedure for this scheme, like they have in France with the ATU scheme for example, and the lack of this is disappointing, particularly for pre-revenue bioscience SMEs who could use the small amounts of revenue it would generate to help fund later stage clinical activities. And, further disappointing because the government in the Strategy for UK Life Sciences specifically stated that “under the Early Access Scheme companies will be reimbursed at an earlier stage in development at a price that recognises the uncertainty of the effectiveness of early stage products”. This risks significantly undermining the attractiveness of the scheme on a global level, which contains many progressive elements.

The detail – three stage process
The announcement envisages a three stage process:

Stage One: Promising Innovative Medicine (PIM) designation. Based loosely on the US Breakthrough Therapy Designation, the PIM would provide an early indication that a product may be a possible candidate for the EAMS (based on early clinical data, e.g. from Phase II studies for example). Government envisage early interaction and collaboration with the NIHR and NICE.

Stage Two: Early Access to Medicines opinion. As described in the original consultation document, a manufacturer would apply and receive an MHRA opinion. A positive opinion would allow for earlier access – outside of a clinical trial – on the basis of Phase III studies but also in some cases Phase II studies.

Stage Three: Licensing and rapid commissioning. A new NICE technology appraisal and NHS England Commissioning process introduced for when products are granted MA. Our understanding is that this would allow for a more rapid assessment through NHS England central commissioning, taking into account MHRA opinion to guide prescribing.

There is a lot of detail we, as a sector, need to understand. For example, is this a linear process where you start at one, passing two and ending up at three, or can a sponsor start at two depending on where their product is in development? How much time, practically speaking, might be saved by going through this route, with a particular emphasis on the commissioning and uptake? How does it differ from a conditional licensing route? These, and many other issues, will I hope be raised at our event, which will come at a good time to discuss it.

Thanks for the input
I hope this note accurately reflects member sentiment about this scheme. I am much indebted to the many BIA member companies and their staff who have contributed to the development of this process over recent years. And as ever I would very much welcome thoughts from the community as we go forward. Today’s announcement provides a blueprint for how the scheme will work, but there is still work ahead to turn it into a practical and utilised scheme. Please get in touch.

Media coverage
There has been significant media coverage since the announcement. BIA members Summit and ReNeuron are both mentioned in the Telegraph. Glyn Edwards of Summit is quoted in the Financial Times and appeared on BBC Breakfast.

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[…] to Medicines Scheme and the introduction of a Promising Innovative Medicine (PIM) designation. I have discussed elsewhere that the proposals have some positive and progressive elements, some disappointing news and aspects […]

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